TAMPA, FL, USA, 23 June 2005–At the request of the U.S. Food and Drug Administration (FDA), ISPE has posted a draft positioning paper on restricted access barrier systems (RABS) for industry review and comment. The positioning paper creates a concise definition of RABS for the pharmaceutical industry, with the goal of reducing confusion about the key elements of RABS and their regulatory requirements. ISPE is a global not-for-profit Society of pharmaceutical manufacturing professionals whose aim is to bring together industry and regulators to “engineer pharmaceutical innovation.” ISPE has posted the draft positioning paper to its Web site at www.ispe.org/rabscomment, and is requesting industry input and comment no later than July 15, 2005.

RABS is a type of barrier system for aseptic processing of pharmaceutical products that reduces interventions into the critical zone, as compared to conventional clean room aseptic processing. There is great confusion in the industry about RABS, its definition, and how it differs from other forms of barrier isolation systems. In order to be classified as a RABS, a system must include the following elements:
Properly designed equipment
Management oversight
A quality system in place
Proper surrounding room design to maintain ISO 5 in critical zone
Proper gowning practice
Proper training
Initial high level disinfection with sporicidal agent
Proper SOP’s for rare interventions
Disinfection
Appropriate line clearance
Documentation of event

To assist pharmaceutical professionals in understanding the regulatory requirements for RABS, the FDA has asked ISPE to provide a definition that the Agency will use in future guidance documents. In response, an ISPE committee has created the draft positioning paper that defines RABS for the industry and describes the “quality by design” and operational characteristics that must be present to constitute a RABS.

“In its ongoing efforts to drive innovation in pharmaceutical manufacturing, the FDA has asked ISPE to be a ‘catalyst for change,'” said Robert P. Best, President and CEO of ISPE. “The RABS definition is an excellent example of the FDA’s efforts to work through ISPE to formulate key positioning and communicate valuable guidance information.”